Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
MOI — Predicate Candidate Screening
28 FDA 510(k) clearances under this product code; the 50 most recent screened below.
127 daysmedian FDA review time
371 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K240403 | Access BR Monitor | Beckman Coulter, Inc. | 2024-05-09 | 90 | 0 |
| K233946 | IMMULITE® 2000 BR-MA | Siemens Healthcare Diagnostics Products, Ltd. | 2024-03-13 | 90 | 0 |
| K192524 | Lumipulse G CA15-3 | Fujirebio Diagnostics,Inc. | 2020-09-04 | 357 | 0 |
| K193489 | ADVIA Centaur BR | Siemens Healthcare Diagnostics, Inc. | 2020-02-13 | 58 | 0 |
| K192777 | ADVIA Centaur CA 15-3 assay | Siemens Healthcare Diagnostics, Inc. | 2019-11-22 | 53 | 0 |
| K181492 | Elecsys CA 15-3 II | Roche Diagnostics | 2018-06-22 | 16 | 0 |
| K171605 | Elecsys CA 15-3 II | Roche Diagnostics | 2018-02-20 | 264 | 0 |
| K100344 | DIMENSION VISTA LOCI CA 15-3 FLEX REAGENT CARTRIDGE, DIMENSI | Siemens Healthcare Diagnostics | 2011-04-18 | 437 | 1 |
| K072612 | ACCESS IMMUNOASSAY SYSTEMS BR MONITOR, AND CALIBRATORS, MODE | Beckman Coulter, Inc. | 2007-10-26 | 39 | 0 |
| K042732 | ARCHITECT CA 15-3 ASSAY | Fujirebio Diagnostics,Inc. | 2004-12-22 | 82 | 0 |
| K033036 | BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOAS | Beckman Coulter, Inc. | 2004-02-03 | 127 | 0 |
| K022178 | CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM | Bayer Diagnostics Corp. | 2002-11-12 | 132 | 0 |
| K013984 | IMMULITE BR-MA, MODEL #LKBR; IMMULITE 2000 BR-MA, MODEL #L2K | Diagnostic Products Corp. | 2002-03-28 | 115 | 2 |
| K012357 | CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM | Bayer Diagnostics Corp. | 2002-02-28 | 218 | 0 |
| K010796 | AIA-PACK BRCA, ST AIA PACK BRCA | Tosoh Medics, Inc. | 2001-08-16 | 153 | 0 |
| K010588 | ELECSYSCA 15-3 II ASSAY | Roche Diagnostics Corp. | 2001-03-28 | 29 | 0 |
| K001468 | ELECSYS CA 15-3 TEST SYSTEM | Roche Diagnostics Corp. | 2000-10-23 | 166 | 0 |
| K983690 | VITROS IMMUNODIAGNOSTIC PRODUCTS CA 15-3 CALIBRATORS,VITROS | Ortho-Clinical Diagnostics, Inc. | 1999-02-02 | 104 | 0 |
| K982680 | CHIRON DIAGNOSTICS CORPORATION ACS: CENTAUR BR IMMUNOASSAY | Chiron Diagnostics Corp. | 1998-10-15 | 76 | 3 |
| K981698 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANT | Chiron Corp. | 1998-07-10 | 57 | 0 |
| K980190 | ACS 180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM) | Chiron Corp. | 1998-03-06 | 45 | 0 |
| K964703 | THE CA 15-3 ASSAY FOR THE TECHNICON IMMUNO 1 SYSTEM (IN VITR | Bayer Corp. | 1997-12-01 | 374 | 0 |
| K964407 | IMX CA 15-3 | Abbott Laboratories | 1997-11-10 | 371 | 3 |
| K965141 | TRUQUANT BR RIA | Biomira USA, Inc. | 1997-10-31 | 312 | 0 |
| K963926 | AXSYM CA 15-3 | Abbott Laboratories | 1997-09-15 | 350 | 4 |
| K970695 | ACS:180 BR (AUTOMATED CHEMILUMINESCENCE SYSTEM FOR THE QUANT | Chiron Diagnostics Corp. | 1997-08-08 | 164 | 0 |
| K971418 | CHIRON DIAGNOSTICS AUTOMATED CHEMILUMINESCENCE SYSTEM (ASC) | Chiron Diagnostics Corp. | 1997-07-17 | 92 | 4 |
| K963803 | CENTOCOR CA 15-3 RIA MODEL NO. 800-033 | Centocor, Inc. | 1997-05-23 | 242 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda